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28 November 2016
On October 31 2016, following the signing of the Comprehensive Economic and Trade Agreement (CETA), Minister of International Trade Chrystia Freeland tabled Bill C-30. This update provides an overview of the main provisions of the bill specifically relevant to pharmaceuticals.
The summary accompanying the bill indicated that it would amend the Patent Act to:
"provide further regulation-making authority in subsection 55.2(4) to permit the replacement of the current summary proceedings in patent litigation arising under regulations made under that subsection with full actions that will result in final determinations of patent infringement and validity".
The new Section 55.2(4)(j) would read as follows:
"The Governor in Council may make regulations respecting the infringement of any patent that, directly or indirectly, could result or results from the making, construction, use or sale of a patented invention in accordance with subsection (1), including regulations…
respecting such proceedings, including the procedure of the court in the matter, the defences that may be pleaded, the remedies that may be sought, the joinder of parties and of rights of action and the consolidation of other proceedings, the decisions and orders the court may make and any appeals from those decisions and orders."
The specifics of the proposed new scheme will not be known until the regulations are published for comment. A scheme more closely aligned to the US Hatch Waxman scheme is possible.
The CETA text includes a requirement to provide for restoration of patent term to account for marketing delays resulting from the time required to obtain regulatory approval. While the European Union has such a system in place called supplementary protection certificates (SPCs), Canada has never had such protection. Section 59 would amend the Patent Act by adding the core certificate of supplementary protection (CSP) provisions in Sections 104-134, which provide as follows:
CETA still requires a positive vote in the European Parliament before it can be provisionally applied. The bill could become law as quickly as the end of 2016, with regulatory amendments to follow.
For further information on this topic please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486) or email (email@example.com). Alternatively, contact Nancy Pei at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514) or by email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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